Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

94 results for "Edan Instruments, Inc."
73–94 of 94
Search insights Median review: 119d Cleared: 100% Top manufacturer: Edan Instruments, Inc. Lead specialty: Cardiovascular
Cleared Jan 06, 2011
CENTRAL MONITORING SYSTEM
K100358 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 328d
Cleared Dec 27, 2010
VITAL SIGNS MONITOR
K102835 · DQA
Edan Instruments, Inc.
Anesthesiology · 89d
Cleared Dec 03, 2010
PC ECG
K102854 · DPS
Edan Instruments, Inc.
Cardiovascular · 65d
Cleared Dec 02, 2010
ELECTROCARDIOGRAPH
K102830 · DPS
Edan Instruments, Inc.
Cardiovascular · 64d
Cleared Nov 24, 2010
VITAL SIGNS MONITOR MODEL M3B
K101539 · DQA
Edan Instruments, Inc.
Anesthesiology · 174d
Cleared Nov 10, 2010
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS
K100797 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 233d
Cleared Oct 28, 2010
ULTRASONIC TABLETOP DOPPLER
K102138 · MAA
Edan Instruments, Inc.
Radiology · 90d
Cleared Aug 10, 2010
SONOTRAX SERIES ULTRASONIC POCKET DOPPLER
K101960 · HEP
Edan Instruments, Inc.
Radiology · 29d
Cleared Apr 01, 2010
SE-601 SERIES ELECTROCARDIOGRAPH
K093869 · DPS
Edan Instruments, Inc.
Cardiovascular · 105d
Cleared Dec 03, 2009
H100B PULSE OXIMETER
K092727 · DQA
Edan Instruments, Inc.
Anesthesiology · 90d
Cleared Nov 10, 2009
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
K092997 · KNG
Edan Instruments, Inc.
Radiology · 43d
Cleared Oct 22, 2009
PC ECG, MODEL SE-1010
K092010 · DPS
Edan Instruments, Inc.
Cardiovascular · 108d
Cleared Jul 24, 2009
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6,...
K091513 · DPS
Edan Instruments, Inc.
Cardiovascular · 63d
Cleared Jun 19, 2009
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K091680 · ITX
Edan Instruments, Inc.
Radiology · 9d
Cleared Jun 03, 2009
SE-601 SERIES ELECTROCARDIOGRAPH
K090367 · DPS
Edan Instruments, Inc.
Cardiovascular · 110d
Cleared May 14, 2009
VITAL SIGNS MONITOR
K083821 · DQA
Edan Instruments, Inc.
Anesthesiology · 143d
Cleared Nov 26, 2008
FETAL & MATERNAL MONITOR, MODEL F6, F9
K082602 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 79d
Cleared Nov 07, 2008
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR
K082369 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 81d
Cleared Mar 11, 2008
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC,...
K080087 · KNG
Edan Instruments, Inc.
Radiology · 60d
Cleared Dec 28, 2007
CADENCE II
K073221 · HGM
Edan Instruments, Inc.
Radiology · 43d
Cleared Sep 02, 2004
CADENCE, MODELS 2001 AND 2002
K040903 · HGM
Edan Instruments, Inc.
Obstetrics & Gynecology · 148d
Cleared May 25, 2004
SONOTRAX ULTRASONIC POCKET DOPPLER
K040480 · KNG
Edan Instruments, Inc.
Obstetrics & Gynecology · 90d